Responsible for managing projects and employees at client sites. Duties include ensuring completion of projects in a timely matter. Point of contact between client and project executors. Support production and engineering with various tasks for validation, quality and manufacturing departments.
- Strategic thinker with strong analytical skills who can translate client needs into actionable value-added projects/results
- Willing to work hands-on, assist with building client libraries, learn from a mentor and become a mentor for others.
- Understands worldwide regulations Draws insights from projects and supplemental research to help drive new and existing growth.
- Ensures activities are efficient, optimized, and client-centric.
- Highly motivated and organized - solutions-oriented leader
- Curious and adaptable - has the ability to transform knowledge into actionable activities
- Able to produce results in a fast-paced, collaborative environment
Essential Duties and Responsibilities
- Perform technical project management such as developing technical approaches, developing project implementation methodologies, monitoring project compliance with appropriate design plans and schedules;
- Lead, direct and develop company personnel through all technical aspects of the project lifecycle;
- Communicate effectively verbally and in writing with project team members regarding project plans, roles and responsibilities and the scope of work for each project; write engineering documentation such as URS/FS/DS;
- Develop, modify and execute complex test procedures for Equipment, Production, Facilities, and Quality (FAT, SAT, IQ, OQ, PQ, PPQ);
- Perform and check engineering analysis related to Process Optimization using engineering tools;
- Write reports to summarize validation/verification/commissioning and/or re-validation/ verification/ commissioning activities;
- Support the resolution of regulatory observations or manufacturing site issues;
- Actively participate in the mentoring, training of junior engineers and development of internal company policies and procedures.
- Responsible for delivery of project vision of the client while providing cost-effective solutions to meet product quality goals for the client.
- Validation Engineer - Bachelor's degree in technical discipline (preferably Engineering) with 2 years professional work experience as Validation Engineer in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.
- Quality Engineer/Specialist - Bachelor's degree in technical discipline (i.e. Pharmaceutical Science, Chemistry, Biochemistry, Biomedical/Biotech Engineering, etc..) with 2 years professional work experience as a Quality Engineer or Quality Assurance or equivalent Quality role in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.
- Two (2) years of years management experience or role with equivalent accountability/ leadership.
- Must have process, facilities and equipment validation experience in pharmaceutical, medical device or biotech industry.
- Experience in Process, Facilities and Equipment Validation experience in pharmaceutical and medical devices
- Experience with design documentation (URS, FS, DS and other engineering specifications)
- Validation (IQ, OQ, PQ, PPQ)
- Quality Systems (Change Control Non-Conformances, Requalification, etc
- Excellent written and verbal communication skills; experience in Microsoft Office Suite.
- Strong working knowledge of FDA regulation and cGMP's.